Novartis' second blockbuster approval barely registers

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/Evgeny_D)
(Image: Getty/Evgeny_D)

Related tags Novartis Piqray Zolgensma

US FDA grants approval for Novartis’ Piqray to be used as combination treatment for advanced or metastatic breast cancer, a potential blockbuster drug.

It may have been the approval of the most expensive treatment in the world​ that grabbed all the headlines, but Novartis actually received a second piece of significant news the same day – the approval of Piqray (alpelisib).

The US Food and Drug Administration (FDA) gave the treatment approval to be used in combination with fulvestrant for postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2), PIK3CA-mutated, advanced or metastatic breast cancer.

In clinical trials, the combination treatment was seen to nearly double median progression-free survival to 11 months, compared to fulvestrant alone.

For these reasons, the company noted in recent investor advice​ that it expects the product to become a blockbuster following its launch.

“The FDA approval of Piqray, which was discovered at the Novartis Institutes for BioMedical Research, marks the first ever treatment specifically for HR+/HER2- advanced breast cancer with a PIK3CA mutation,” ​said Susanne Schaffert, CEO, Novartis Oncology.

Patients will be selected to receive the treatment based on the presence of PIK3CA mutations, which will be tested for using the ‘therascreen’ companion diagnostic test that was approved alongside Piqray’s approval by the FDA.

The approval means that Novartis received FDA nods for two treatments the company estimates will become blockbusters on the same day, among a pipeline of over 25 potential blockbuster products through to 2023.

Even though its pipeline appears well-stocked, this has not stopped Novartis from carrying out a number of smaller, bolt-on acquisitions, such as its $1.6bn (€1.4bn) of IFM Tre​ and with a deal to acquire for CellforCure​.

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